Table of Contents for ISO 9001 : 2008 Explained


List of Figures and Tables xiii
Preface xv
Chapter 1 Introduction 1
The Eight Quality Management Principles
3
Chapter 2 Quality Management System and General Documentation 15
Clause 4.1
16
Implementation Tips and Typical Questions to Ask for Conformity
18
Definitions
19
Clause 4.2
21
Implementation Tips and Typical Questions to Ask for Conformity
26
Definitions
26
Clause 4.2.2
27
Implementation Tips and Typical Questions to Ask for Conformity
28
Definitions
29
Clause 4.2.3
30
Clause 4.2.4
30
Implementation Tips and Typical Questions to Ask for Conformity
35
Definitions
36
Considerations for Documentation
37
Chapter 3 Management Responsibility 39
Clause 5.1
40
Clause 5.2
40
Implementation Tips and Typical Questions to Ask for Conformity
41
Definitions
43
Considerations for Documentation
44
Clause 5.3
44
Implementation Tips and Typical Questions to Ask for Conformity
47
Definitions
48
Clause 5.4
49
Implementation Tips and Typical Questions to Ask for Conformity
50
Definitions
54
Considerations for Documentation
54
Clause 5.5
55
Implementation Tips and Typical Questions to Ask for Conformity
57
Definitions
58
Clause 5.6
59
Implementation Tips and Typical Questions to Ask for Conformity
61
Definitions
62
Chapter 4 Human and Other Resources 65
Clause 6.1
66
Implementation Tips and Typical Questions to Ask for Conformity
67
Definitions
69
Considerations for Documentation
69
Clause 6.2
70
Implementation Tips and Typical Questions to Ask for Conformity
71
Definitions
72
Considerations for Documentation
72
Clause 6.2.2
72
Implementation Tips and Typical Questions to Ask for Conformity
74
Definitions
75
Considerations for Documentation
75
Clause 6.3
76
Implementation Tips and Typical Questions to Ask for Conformity
77
Definitions
78
Considerations for Documentation
78
Clause 6.4
79
Implementation Tips and Typical Questions to Ask for Conformity
80
Definitions
81
Considerations for Documentation
81
Chapter 5 Planning of Product Realization and Customer-Related Processes 83
Clause 7.1
84
Implementation Tips and Typical Questions to Ask for Conformity
86
Definitions
87
Considerations for Documentation
88
Clause 7.2
89
Clause 7.2.1
89
Implementation Tips and Typical Questions to Ask for Conformity
90
Definitions
91
Considerations for Documentation
91
Clause 7.2.2
92
Implementation Tips and Typical Questions to Ask for Conformity
93
Considerations for Documentation
95
Clause 7.2.3
95
Implementation Tips and Typical Questions to Ask for Conformity
96
Considerations for Documentation
97
Chapter 6 Design and Development 99
Clause 7 3
100
Clause 7.3.1
100
Implementation Tips and Typical Questions to Ask for Conformity
101
Definitions
101
Considerations for Documentation
102
Clause 7.3 2
103
Implementation Tips and Typical Questions to Ask for Conformity
103
Definitions
104
Considerations for Documentation
106
Clause 7.3.3
106
Implementation Tips and Typical Questions to Ask for Conformity
108
Definitions
109
Considerations for Documentation
109
Clause 7.3.4
110
Implementation Tips and Typical Questions to Ask for Conformity
111
Definitions
112
Considerations for Documentation
112
Clause 7.3.5
112
Implementation Tips and Typical Questions to Ask for Conformity
113
Definitions
114
Considerations for Documentation
114
Clause 7.3.6
115
Implementation Tips and Typical Questions to Ask for Conformity
115
Definitions
117
Considerations for Documentation
117
Clause 7.3.7
118
Implementation Tips and Typical Questions to Ask for Conformity
118
Considerations for Documentation
119
Chapter 7 Purchasing 121
Clause 7.4
122
Clause 7.4.1
122
Implementation Tips and Typical Questions to Ask for Conformity
123
Definitions
124
Considerations for Documentation
124
Clause 7.4.2
125
Implementation Tips and Typical Questions to Ask for Conformity
125
Definitions
126
Considerations for Documentation
126
Clause 7.4.3
127
Implementation Tips and Typical Questions to Ask for Conformity
128
Definitions
129
Considerations for Documentation
130
Chapter 8 Production and Service Provision 131
Clause 7.5
132
Clause 7.5.1
132
Implementation Tips and Typical Questions to Ask for Conformity
133
Definitions
136
Considerations for Documentation
138
Clause 7.5.2
139
Implementation Tips and Typical Questions to Ask for Conformity
140
Definitions
142
Considerations for Documentation
142
Clause 7.5.3
143
Implementation Tips and Typical Questions to Ask for Conformity
144
Definitions
145
Considerations for Documentation
145
Clause 7.5.4
146
Implementation Tips and Typical Questions to Ask for Conformity
147
Definitions
148
Considerations for Documentation
148
Clause 7.5.5
149
Implementation Tips and Typical Questions to Ask for Conformity
149
Definitions
150
Considerations for Documentation
150
Clause 7.6
151
Implementation Tips and Typical Questions to Ask for Conformity
153
Definitions
154
Considerations for Documentation
154
Chapter 9 Measurement 155
Clause 8.1
156
Implementation Tips and Typical Questions to Ask for Conformity
157
Definitions
159
Considerations for Documentation
159
Clause 8.2
159
Clause 8.2.1
159
Implementation Tips and Typical Questions to Ask for Conformity
160
Definitions
162
Considerations for Documentation
162
Clause 8.2.2
163
Implementation Tips and Typical Questions to Ask for Conformity
164
Definitions
168
Considerations for Documentation
171
Clause 8.2.3
171
Implementation Tips and Typical Questions to Ask for Conformity
172
Definitions
173
Considerations for Documentation
174
Clause 8.2.4
174
Implementation Tips and Typical Questions to Ask for Conformity
175
Definitions
176
Considerations for Documentation
178
Chapter 10 Control of Nonconforming Product 179
Clause 8.3
180
Implementation Tips and Typical Questions to Ask for Conformity
181
Definitions
183
Considerations for Documentation
184
Chapter 11 Analysis of Data 187
Clause 8.4
188
Implementation Tips and Typical Questions to Ask for Conformity
189
Definitions
193
Chapter 12 Improvement 197
Clause 8.5
198
Clause 8.5.1
198
Implementation Tips and Typical Questions to Ask for Conformity
199
Definitions
201
Considerations for Documentation
203
Clause 8.5.2
203
Implementation Tips and Typical Questions to Ask for Conformity
205
Definitions
206
Considerations for Documentation
207
Clause 8.5.3
207
Implementation Tips and Typical Questions to Ask for Conformity
209
Definitions
211
Considerations for Documentation
212
Chapter 13 Implementation of a Quality Management System Conforming to ISO 9001:2008 213
Key Success Factors
214
Learn About Quality Management Systems
215
Engage Top Managers
218
Achieve and Maintain a Clear Understanding of Why You Need a Formal Quality Management System
218
Develop Your Organization's Principles
219
Align Your Organization's Overall Business Objectives and the Quality Objectives
219
Plan the Implementation Process
220
Identify the Important Processes and Associated Controls
222
Develop a Focus on Continual Improvement
223
Keep the Processes, Documentation, and Overall Quality Management System as Simple and Easy to Understand as Possible
224
Audit During and After Implementation
225
Make Management Reviews Meaningful for Both the Organization and to Each Top Manager
225
Summary
226
Endnotes
226
Chapter 14 Auditing the Process-Based Quality Management System 227
Quality Management Systems Structure and the Implications for Internal Auditing
228
Auditing the Process-Based Quality Management System
232
Additional Considerations
237
Other Standards Providing Auditing Guidance
238
Summary
238
Endnote
238
Chapter 15 Use of ISO 9001 and Sector Applications 239
Introduction
240
Preventing Proliferation
241
Classifications of Management Systems Standards
243
Sector Applications of ISO 9001
244
Use of ISO 9001
244
Internal Use
244
Supplier Qualification
245
Regulatory Requirement
245
Conclusion
259
Annex A 261
Table A.1 Correspondence between ISO 9001:2008 and ISO 14001:2004
262
Table A.2 Correspondence between ISO 14001:2004 and ISO 9001:2008
268
Annex B 273
Table B.1 Changes between ISO 9001:2000 and ISO 9001:2008
274
Index 291